Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team.
Position Summary
Responsible for management of the site’s Quality Systems including but not limited to cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate and finished product, review/coordination of investigations (including customer complaints), approval of deviations, change controls, and CAPAs; approval of validation/qualification documents; hosting of external agencies and/or customer audits. The manager is responsible for personnel activities such as: reviews, workload management and coordination of training.
Responsibilities Include:
- Responsible for the functions associated with the Quality System, including oversight and coordination of training, investigations (including customer complaints), deviations, change controls, CAPAs and validation/qualification documents.
- Participates in the Material Review Board including assessment of customer complaints. Participates in assigning and addressing all customer communications.
- Oversee the investigation of process deviations, product failures, customer complaints or facility incidents and assure proper documentation and investigation per established procedures. Approves minor deviations and related CAPAs.
- Writes customer-related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)
- Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.
- Compiles and communicates metrics associated with the Quality System to management as required.
- Oversee the establishment/maintenance of relevant procedures/documents
Requirements:
Education:
- Associate's Degree, Bachelor's Degree in natural sciences or above preferred
Experience:
- 10+ years of experience, 15+ years preferred
- History of developing Quality Systems’ teams’ skills with examples of coaching to goals, identifying strengths, mentoring, encouraging cross-functional collaboration
- Experience with professional, transparent compliance engagement with external authorities
- Demonstrate experience in inspection, inspection readiness, coordination, and proper documentation. Coaching team experts to speak on documents as needed.
- Experience in relationships with managing consultants
- Experience managing metrics reporting for technical aspects, navigating change control
- Experience managing the needs for annual product reviews, vendor audits
- Experience escalating issues to solve problems
- Coach sales to understand compliance
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
Skills Required
- Associate's degree or bachelor's degree in natural sciences or higher
- 10+ years of experience
- Experience developing Quality Systems teams through coaching, mentoring, goal-setting, and cross-functional collaboration
- Experience engaging professionally and transparently with external authorities on compliance matters
- Experience with inspections, inspection readiness, coordination, and documentation
- Experience coaching subject-matter experts to speak about documents during inspections
- Experience managing consultants
- Experience managing technical metrics reporting and navigating change control
- Experience managing annual product reviews and vendor audits
- Experience escalating issues to resolve problems
- Experience coaching sales teams on compliance
- 15+ years of experience
What We Do
Scientific Protein Laboratories is a leading global supplier of high-quality active pharmaceutical ingredients (APIs). Specializing in cGMP biopharmaceutical manufacturing, the company is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. Based in Waunakee, Wisconsin, it serves the pharmaceutical, veterinary, and food industries globally.
